Articles Posted inDangerous Drugs

Bahe Cook Cantley & Nefzger is currently evaluating legal claims on behalf of men who may have suffered cardiac problems due to their use of AndroGel and other similar testosterone therapy medications.

The FDA began reviewing these products for safety in January after two studies published by the Journal of the American Medical Association (JAMA) showed that on average the medications doubled the risk of stroke, heart attack, or even death after a mere 90 days of treatment in men over the age of 65 with no heart problems, as well as in men under age 65 with heart problems. (Stephen R. Braun, “Promoting Low T: A Medical Writer’s Perspective” JAMA Inter. Med. 2013; Lisa M. Schwartz, et. Al, “Low T as in Template: How to Sell Disease” JAMA Intern. Med. 2013). More recent studies have shown that all men may face a 30% risk increase within weeks of beginning treatment with these products.

Sales of Testosterone replacement therapy products have doubled since 2006, and are expected to triple to $5 billion by 2017. Some of the more popular testosterone therapy medications include Androgel®, Androderm®, Fortestra®, Axiron®, Testim®, Bio-T-Gel®, Delatestryl®, Depo-Testosterone®, Striant®, and Testopel®. If you or someone you know are using any of these drugs, take caution. It is also important to be wary of the generic versions of these products.

Since the FDA announced its investigation, law suits against pharmaceutical manufacturers have been increasing exponentially. Multiple law suits are now active across the country, with claims that (1) the companies failed to provide adequate warnings regarding the increased risks to cardiovascular health and that (2) marketing tactics were not up to the required ethical or legal standards and in fact resulted in prescriptions being issued to men who did not even have low testosterone levels. The most recent of these lawsuits was filed against Endo Pharmaceuticals, Inc. on May 8th, less than two weeks ago. Our firm is currently investigating and accepting these cases.

In an effort to further educate himself and increase the firm’s knowledge in the area, Bahe Cook Cantley & Nefzger PLC partner Will Nefzger attended an American Association for Justice seminar on the emerging Testosterone Replacement Therapy (TRT) Litigation. The seminar offered a thorough examination of the history of the drug, the marketing, the science behind the dangerous side effects, the possible causes of action and the potential defenses by the drug makers.

The overarching theme that arises when examining this drug and its history is that the drug makers essentially created the disease now known as low T. While the drug initially gained approval to treat real medical conditions, like hypogonadism, the pharmaceutical industry began a marketing blitz targeting men who did not necessarily have the medical condition, but were experiencing tiredness, grumpiness, loss of sexual drive and other “symptoms.”

The problem is that now studies are showing that the TRT drugs have far more of increased risks than the drug makers have ever warned of, including heart attacks, strokes and severe, life-threatening blood clots. We continue to evaluate and accept these cases.

The FDA announced that it will undertake an investigation of the popular low testosterone treatment products that it has previously approved. Two separate studies recently published suggest an increased risk in heart attacks, strokes and death.

The FDA will share the conclusions and recommendations of the evaluation once it is complete, but for now is not advising men to stop taking the drugs. The FDA does advise health care professionals that when prescribing, they should weigh the potential risks of the drugs versus the likely benefits. In any event, they encourage consumers and health care providers to report adverse events, should they occur.

An increasing number of women nationwide are filing lawsuits against the manufacturer NuvaRing, Merck & Co. Many of these lawsuits allege that NuvaRing’s manufacturer failed to adequately warn women, their physicians, and the public at large of the known complications, such as a high risk of developing blood clots, associated with the product. Dozens of these lawsuits allege that NuvaRing caused the death of a loved one due to complications associated with the product.

Many of these federal NuvaRing lawsuits were consolidated into a multi-district litigation in the Eastern District of Missouri. Many cases continue to be added to this litigation as they are filed nationwide. Currently the number of cases in the Missouri multidistrict litigation is approaching 2,000.
Approved by the FDA in 2002, NuvaRing is a device designed to prevent pregnancy by secreting both progestin and estrogen from a flexible ring that is inserted within the vagina. Health experts have increasingly been warning consumers of the higher risk of blood clots associated with the NuvaRing than is associated with the traditional pill-form of birth control. The New England Journal of Medicine recently released a study which noted that the NuvaRing increases the risk of blood clots by as much as 33%.

The newest plaintiffs to file a lawsuit for injuries sustained against NuvaRing manufacturer, Merck, did so in the West Virginia Southern District Court. The West Virginia couple alleges that the woman developed a blood clot in the right transverse sinus as a result of the NuvaRing.

The NuvaRing is a device designed to prevent pregnancy by secreting both progestin and estrogen from a flexible ring that is inserted within the vagina.
Health experts have increasingly been warning consumers of the higher risk of blood clots associated with the NuvaRing than is associated with the traditional pill-form of birth control. As previously reported, the New England Journal of Medicine recently released a study which noted that the NuvaRing increases the risk of blood clots by as much as 33%.

After being denied in August 2012 by the United States Judicial Panel on Multidistrict Litigation, the growing number of plaintiffs filing lawsuits against Lipitor manufacturer, Pfizer, will again seek consolidation of suits in January 2014. The panel based their prior denial on the low number of cases that had been filed as of August 2012. As more and more lawsuits mount against Pfizer however, the Lipitor litigation seems like a clear candidate for centralization.

When cases are consolidated in a multi-district litigation, the plaintiffs all maintain individual suits against the defendant. This is unlike a class action lawsuit, where all plaintiffs with similar claims are joined together. By maintaining each case’s individuality but centralizing cases with similar claims, the assigned judge can more efficiently rule on issues related to each case because they have more familiarity with the general facts of the cases. Consolidation also allows for greater efficiency because rulings which affect all the cases in a common way can be decided by a judge just once and applied uniformly to all the consolidated claims.

Many of the lawsuits are alleging that Pfizer failed to completely and adequately modify the product’s warning labels despite being asked to modify the label by the FDA. As such, the medical community, patients and the public at-large have been improperly warned about the risks associated with use of the product. Such risks include the increased risk of developing type-2 diabetes, especially in post-menopausal women. A University of Massachusetts study found that women taking the drug were 50% more likely to develop diabetes than women not taking Lipitor. Other risks include skeletal muscle side effects, liver damage, kidney damage, and memory loss or confusion.
Bahe, Cook, Cantley & Nefzger is currently reviewing and accepting these cases.

The NuvaRing, released in 2002, is a popular alternative to the traditional pill-form of hormonal birth control. Manufactured by Merck Co., the product has been prescribed by doctors roughly 44 million times in the last decade alone. Despite its popularity, many women are coming forward with claims that the device has caused serious side effects, which in some cases, have proven deadly.
One Cleveland woman had only been using the NuvaRing for a month when she went to the emergency room to be treated for unbearable migraine headaches in June 2008. Doctors discovered that Lyndsey Agresta had a blood clot which caused her brain to hemorrhage. Agresta subsequently suffered a massive stroke which required portions of her brain to be removed, left her paralyzed and ultimately led to her death in January 2009. Agresta’s physicians believed the blood clot developed via use of the NuvaRing.
Many are pointing to negotiations between the FDA and NuvaRing’s original manufacturer, Organon, regarding the warning label on the product prior to it being released to the public. Based on clinical trials where an otherwise healthy, young, non-smoking woman suffered a blood clot after using the NuvaRing, the FDA had concerns related to an increased risk of blood clots. After strong opposition from the manufacturer, the FDA allowed the product to be released with only a general warning regarding the risk of blood clots associated with almost all hormonal contraceptives. No warning was included regarding the occurrence of a blood clot in what was typically considered to be a low-risk patient in connection to use of the NuvaRing.

Earlier this month a Rineyville, Ky. woman filed a lawsuit against Lipitor manufacturer Pfizer, Inc. in the United States District Court for the Western District of Kentucky. According to the complaint, Helen Robinson alleges that she developed Type-2 diabetes as a result of taking the cholesterol-lowering statin drug Lipitor.
Robinson began taking Lipitor in 2008 in order to lower her levels of LDL cholesterol and thereby reduce the risk of developing heart disease. In August 2012, Robinson was diagnosed with hyperglycemia and in December of that year she was diagnosed with Type-2 diabetes.
Robinson’s complaint, filed on Dec. 5, 2013, states that despite Pfizer’s knowledge that Lipitor use is causally linked to the onset of Type-2 diabetes, the company failed to adequately warn physicians and consumers of the risk of developing Type-2 diabetes.

Health experts have increasingly been warning consumers of the higher risk of blood clots associated with the NuvaRing than is associated with the traditional pill-form of birth control. The New England Journal of Medicine recently released a study which noted that the NuvaRing increases the risk of blood clots by as much as 33%.

Many women have experienced blood clots, strokes, and/or pulmonary embolisms as a result of implantation with the NuvaRing. As of November 18, 1,563 cases have been filed in the Eastern District of Missouri alone, where lawsuits alleging similar claims of fact against NuvaRing manufacturer Merck have been consolidated into a multi-district litigation.

NuvaRing is a device designed to prevent pregnancy by secreting both progestin and estrogen from a flexible ring that is inserted within the vagina. Approved in 2002 by the FDA, plaintiff’s lawyers have stated that more than 100 women have died as a result of the NuvaRing, most often because of blood clots.

The American Heart Association recently altered guidelines which dictate what constitutes dangerous levels of “bad” cholesterol. The new guidelines will affect as many as 25%, or 35 million Americans over the age of 40.

Specifically, the guidelines now dictate that Americans with “bad” cholesterol levels over 190 should be prescribed statin drugs. Such drugs reduce the level of triglycerides and cholesterol in the blood by lowering the amount of cholesterol produced by the liver. Statins include popular and well-known drugs such as Lipitor, Crestor, Levacor and Zocor.
While effectively lowering cholesterol levels, these drugs are far from risk free. In fact, as Bahe, Cook, Cantley & Nefzger previously reported, lawsuits are mounting against the manufacturer of Lipitor, Pfizer Inc., by women who developed Type-2 diabetes, allegedly from the use of the product. Among other claims, many of these Plaintiffs are alleging that Pfizer failed to adequately warn of the risk of developing type-2 diabetes, despite the FDA requiring more explicit warnings.